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Ann Thorac Surg 2002;74:1899-1900
© 2002 The Society of Thoracic Surgeons
a Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
* Address reprint requests to Dr Edmunds, Editor, The Annals of Thoracic Surgery, 5000 Ravdin Court, Hospital of the University of Pennsylvania, 3400 Spruce St, Philadelphia, PA 19104-4283, USA.
e-mail: ats{at}uphs.upenn.edu
Over the ages human mousers strive to build "better" mousetraps, but none approach the performance of the family cat, so the search continues. Similarly cardiothoracic surgeons and their industrial partners continually search for better ways to improve the safety and efficacy of operations and perioperative care. Change implies progress, but neither change nor progress is a synonym for "better." New technology is progress, but is it better? That is the question.
The ongoing revolution for minimizing the surgical incision has prompted an explosion in new technology, which includes but is not limited to new devices, systems, machines, equipment, instruments, monitors, blood and tissue contact surfaces and implantable materials designed for improving care and outcomes of patients. Most new technology is developed by industry in cooperation with one or more surgeons, who either initiated the "idea" or who were recruited during development or the introductory phase of a marketing campaign. These "surgical partners" assist the company in obtaining Food and Drug Administration (FDA) approval, carry out initial animal or human evaluations and frequently have a financial relationship with the company.
There are several problems with this system. Surgeon-partners often have an intellectual attachment to the new technology and may have a financial stake and, therefore, are not sufficiently detached to objectively evaluate indications for use, efficacy and safety of a new device, procedure or system except possibly under FDA mandated protocols. All new devices and most new technology require FDA premarket approval; however, manufacturers provide all data that are reviewed by the FDA and rigorous, independent, objective evaluation is usually not done before the data are submitted. The FDA posts summaries of safety and efficacy information of approved products on their website, but the reviewed, detailed data are not disclosed and remain proprietary and not available.
Sometimes implementation of new technology involves a "learning curve," as surgeons acquire the technical skills necessary for consistently successful applications. Once surmounted proficient surgeons are often "convinced" of the superiority of the new technology for patients, who are consciously or unconsciously selected. Their convictions and competitive market incentives may preclude their participation in prospective randomized controlled trials. Other surgeons sometimes adopt the unevaluated new technology in response to competitive pressures. Bad experiences are infrequently reported. Thus most, if not all, new technology for cardiothoracic surgery is evaluated in the marketplace over a period of years. Like it or not, this is reality.
The Annals of Thoracic Surgery recognizes the thirst for reliable information regarding new technology and also recognizes the realities surrounding the introduction of new technology into the practice of cardiothoracic surgery. The Annals cannot fund, demand, design and police scientifically rigorous, independent evaluation studies, but can make a contribution toward that goal. In the end, either government or, better, surgeons mindful of their patients’ welfare must set aside personal interests to demand critical, objective, independent evaluations of new technology before clinical application. The Annals plans to encourage and provide a forum for these efforts.
The Annals introduces a "New Technology" section for publication of high quality articles that objectively evaluate new technology before widespread adoption by mainstream cardiothoracic surgeons. These articles will describe and evaluate new devices, implants, machines, systems, equipment and instruments that are relevant to the practice of cardiac or general thoracic surgery. The articles will be descriptive, but must address safety, efficacy and clinical need of the new product or procedure. Articles describing bench and animal testing of soon-to-be marketed products are preferred; these are at the cutting edge. Authors of clinical articles describing early experience with new technology may choose to be peer reviewed as New Technology articles, original scientific articles, how-to-do-it articles or case reports.
Format
Peer-reviewed papers accepted for publication will appear in The Annals after original scientific articles in each of the two major sections: Cardiac Surgery and General Thoracic Surgery. The title page of the section will carry the banner "New Technology"; the formatting style will be distinctive and page numbers consecutive and undistinguishable from other page numbers in the journal. The length of the articles is limited to 2500 words including references. The abstract is structured as follows: Purpose; Description; Evaluation; Conclusions, and is limited to 175 words. The number of illustrations is not limited, but is controlled by the editor and common sense. References are limited to 10. A section titled "Disclosures and Freedom of Investigation" (discussed below) appears at the end of the article, before the reference list.
Peer review
At least one editorial board member and two or three additional guest reviewers review each submission. The criteria for acceptance differ from the criteria used for original scientific articles. Articles describing new technology are necessarily descriptive and do not pose or test a hypothesis. A reviewer will judge the probable importance or usefulness of the technology and the problem that it addresses; the newness and innovation of the technology; how well the technology is described and illustrated; the methods used to test the technology; and the results obtained. The article should describe the protocol used for evaluation; the reasons for selecting the methods of testing and evaluation; and all studies used in the evaluation. The ease and difficulties in application; successes and failures; advantages; and all complications should be described. The reviewer will also look for whether late adverse events are included or should be included in the evaluation. The conclusion section should summarize the indications, deficiencies and drawbacks. The article should have an objective, dispassionate tone and avoid the enthusiasm of an advertisement or endorsement.
Disclosures and freedom of investigation
Freedom of Investigation is defined as freedom from outside interests in controlling the design of the study, acquisition of data, collection, analysis and interpretation of data and having freedom to fully disclose all results. All authors must declare that they have had full freedom of investigation and sign the Conditions for Publication form attesting that fact. Company employees may be coauthors, but they also must sign the conditions form regarding freedom of investigation.
Under the heading "Disclosures and Freedom of Investigation" nonemployee and employee author-investigators will state the relationship between themselves and the company and/or inventor of the evaluated technology. This disclosure statement will include the sources of all funds used to perform the evaluation and whether or not the tested technology was purchased, borrowed, or donated to the institution of the independent investigators. The disclosure statement is mandatory for all New Technology articles. The disclosure statement will appear under the heading "Disclosures and Freedom of Investigation" after the text, before "References."
The financial relationships between the company and each author are disclosed on the Conditions for Publications form and appear in the "Conflict of Interest Box" on the title page. This statement identifies authors who are employees (full or part time) of the company or subcontractor and also the existence of a financial relationship between the company and each nonemployee of the company or subcontractor. The term "financial relationship" is defined on the Conditions for Publication form.
Commentary
Each New Technology article will be followed by a commentary written by the editorial board member who reviewed the article. This commentary will address the strengths and weaknesses of the evaluation and the results of the evaluation in terms of safety, efficacy and indications for use of the new technology. The commentary is designed to provide balance to the article from a representative of The Annals. A disclaimer following the commentary will indicate that publication of the article does NOT indicate endorsement of a product by The Annals, The Society of Thoracic Surgeons or the Southern Thoracic Surgical Association.
Comment
The New Technology section cannot succeed without the strong support of our entire profession. The editorial board of The Annals and the leadership of The Society of Thoracic Surgeons and the Southern Thoracic Surgical Association have carefully reviewed this initiative and surrounding issues and have unanimously endorsed the experiment. They recognize that we must have rigorous, objective, independent evaluation of new products and procedures for the benefit of both our patients and ourselves. It is better to do this before products are widely distributed across the marketplace than afterwards. The realities of the present system are not in the best interests of patients or practicing physicians and as the public becomes more informed, the government may take interest. We, the profession, must set the standards for evaluation of new technology; the public expects this and will sooner or later demand this. Either the profession leads or the government imposes. We all have a lot to lose if the latter occurs.
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